Search for : FDA : Page 34

FDA approves Gamifant® (emapalumab-lzsg) as first-ever treatment for adults and children with Macrophage Activation Syndrome in Still's disease

PR Newswire ( Middle East ) 2025/6/28

Approval based on the pooled analysis of our pivotal EMERALD and NI-0501-06 studies, showing 54% of patients treated with Gamifant achieved...

97 Views
SFDA penalizes food safety violators

ٍٍٍSaudi Gazette ( Saudi Arabia ) 2025/6/26

Saudi Gazette report RIYADH — The Saudi Food and Drug Authority (SFDA) has taken punitive measures against erring food establishments in var...

121 Views
Novo Nordisk continues efforts to support patient access to authentic, FDA approved Wegovy® and prioritize patient safety

PR Newswire ( Middle East ) 2025/6/26

Novo Nordisk announces collaboration with WeightWatchers to offer patients living with obesity access to FDA-approved Wegovy® through NovoCa...

129 Views
FDA requires updated warning about rare heart risk with COVID shots

News10NBC ( Middle East ) 2025/6/25

WASHINGTON (AP) — The Food and Drug Administration said Wednesday it has expanded existing warnings on the two leading COVID-19 vaccines abo...

151 Views
Natiowide Shrimp Recall Update as FDA Sets Highest Alert

Newsweek ( Middle East ) 2025/6/25

Approximately 46,000 pounds of the food was recalled after being distributed across the United States.

114 Views
FDA probes deaths linked to Sarepta’s gene therapy for muscular dystrophy

Daily Sun ( Middle East ) 2025/6/25

THE U.S. Food and Drug Administration said on Tuesday that it is investigating reports of two deaths due to acute liver failure in non-ambul...

104 Views
FDA Extends Ruxolitinib Cream Review Period for Pediatric AD

Medscape ( Middle East ) 2025/6/25

The supplemental application is based on data from a phase 3 study of children aged 2-12 years with mild-to-moderate AD, randomly assigned t...

94 Views
Two Children Dead After Gene Therapy: Florida Attorney Raises Alarms About FDA Oversight

PR Newswire ( Middle East ) 2025/6/24

PALM BEACH GARDENS, Fla., June 24, 2025 /PRNewswire/ -- A second child has died after receiving Elevidys, an experimental gene therapy for D...

80 Views
SFDA designated as WHO Regional Centre for Nutrition Collaboration

ٍٍٍSaudi Gazette ( Saudi Arabia ) 2025/6/24

Saudi Gazette report RIYADH — The World Health Organization (WHO) has officially designated the Saudi Food and Drug Authority (SFDA) as its...

107 Views
Implantica submits the last and final module 3 of the FDA PMA Application for RefluxStop® for US market approval

PR Newswire ( Middle East ) 2025/6/24

VADUZ, Liechtenstein, June 24, 2025 /PRNewswire/ -- Implantica AG (publ.), a MedTech company at the forefront of introducing advanced techno...

89 Views
Datroway Gains Second FDA Nod With NSCLC Approval

Medscape ( Middle East ) 2025/6/24

The antibody drug conjugate, previously approved for HR+ HER2- breast cancer, is also now indicated for certain previously treated EGFR-muta...

96 Views
Breakthrough in HIV Prevention: FDA Gives Approval to New Drug

PRESSBEE ( Middle East ) 2025/6/21

The recent approval of lenacapavir, marketed as Yeztugo, by the FDA marks a pivotal advancement in HIV prevention strategies. As the first a...

224 Views
FDA approves breakthrough HIV prevention drug

PRESSBEE ( Middle East ) 2025/6/21

The recent approval of lenacapavir, marketed as Yeztugo, by the FDA marks a pivotal advancement in HIV prevention strategies. This injectabl...

305 Views
USFDA okays Lenacapavir: Affordable, generic India-made drug key to boost global HIV prevention

News room odisha ( Middle East ) 2025/6/21

New Delhi: While Gilead Sciences’ HIV prevention drug lenacapavir got approved by the US Food and Drug Administration (FDA), its made-in-In...

123 Views
Supreme court widens court options for vaping companies pushing back against FDA rules

GreeleyTribune ( Saudi Arabia ) 2025/6/20

By LINDSAY WHITEHURSTWASHINGTON (AP) — The Supreme Court sided with e-cigarette companies on Friday in a ruling making it easier to sue ove...

118 Views